Kornimate/medical-research-clean huggingface dataset:
comparison of scores for early brain damage assessment at intensive care unit admission after cardiac arrest

Conditions: Cardiac Arrest

Summary: even in patients with successful return of spontaneous circulation (rosc), outcome after cardiac arrest remains poor. the overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. several studies have already shown that early interventions performed after rosc, such as treatment of the cause, targeted temperature management, optimal hemodynamic management and extra-corporeal life support in selected patients, could improve the outcome in post-cardiac arrest patients. however, the decision process regarding the allocation of these resources, in parallel with the management of patients' proxies, remains a complex challenge for physicians facing these situations. consequently, several prediction models and scores have been developed in order to stratify the risk of unfavorable outcome and to discriminate the best candidates for post-resuscitation interventions. overall, several scores exist, but external validation are lacking and direct comparisons are needed to assess relative interest of scoring systems. indeed, establishing the optimal scoring system is crucial, for optimal treatment allocation and appropriate information to relatives.


Eligibility criteria:
inclusion criteria: * all adult patients, major, admitted to intensive care after cardiac arrest (after both in and out-of hospital cardiac arrest), * comatose (defined by glasgow score ≤ 8) on admission, exclusion criteria: * cardiac arrest occurring intra-hospital, * minor patient, * major patient under guardianship, * protected persons, * prior inclusion in the study

Keywords: cardiac arrest intensive care unit mechanical ventilation
a multi-reader multi-case pivotal trial

Conditions: Breast Cancer

Summary: the purpose of this pivotal reader study is to assess the comparative accuracy of fujifilm ffdm plus dbt versus ffdm alone in the detection of breast cancer.

the safety and effectiveness of ffdm + dbt are both linked to the ability of radiologists interpreting ffdm + dbt images to accurately diagnose breast cancer. each study endpoint therefore addresses both safety and effectiveness.

Eligibility criteria:
inclusion criteria: * eligible subjects under protocol fmsu2013-004a, defined as female subjects with known true clinical status and with complete ffdm and dbt examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites. * meet none of the exclusion criteria under protocol fmsu2013-004a. exclusion criteria: * subjects who are in violation of protocol fmsu2013-004a. * subjects who meet exclusion criteria under protocol fmsu2013-004a. * subjects with unknown clinical status. * any subject whose positive mammogram was not read during the truthing process (see section 8) will not be considered for the pivotal mrmc reader study.

Keywords: mammography
usefulness of an ultraportative ultrasound device in the management of intra hospital emergencies

Conditions: Respiratory Failure; Failure; Cardiac

Summary: estimate if the use of a portable cardiac echograph for intra-hospital emergencie improves the performances diagnose in the bed of patient in department of conventional medicine. the concordance between the initial medical diagnosis (previous the utilsation of portable echograph) and the final diagnosis (after portable echograph utisation) will be evaluated. these evaluation will be performed after retrospective review of the medical files


Eligibility criteria:
inclusion criteria: * respiratory or cardiac distress exclusion criteria: * pulmonary or cardiac patient transplant morphologic abnormalities patient in rescucitation care unit
development and evaluation of a medical intervention for early childhood caries

Conditions: Early Childhood Dental Caries

Summary: this study aimed to evaluate the effect of three forms of continuing medical education (cme) on provision of preventive dental services to medicaid-enrolled children by medical personnel in primary care physician offices.

practice-based, randomized controlled trial. setting: 1,400 pediatric and family physician practices in north carolina providing care to an estimated 240,000 medicaid-eligible children aged 0-3 years. interventions: group a practices (n=39) received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish. group b practices (n=41) received the same as group a and were offered weekly conference calls providing advice and support. group c practices (n=41) received the same as group b and were offered in-office visit providing hands-on advice and support. outcome measures were computed from reimbursement claims submitted to nc division of medical assistance. primary outcome measure: rate of preventive dental services provision per 100 well-child visits. secondary outcome measure: % of practices providing 20 or more preventive dental visits.

Eligibility criteria:
inclusion criteria: * pediatric or family physician medicaid practice in north carolina exclusion criteria: * participation in related pilot study

Keywords: early childhood caries - ecc prevention continuing medical education randomized controlled trial
faecal incontinence in prostate cancer survivors treated whith radiotherapy

Conditions: Faecal Incontinence; Prostate Cancer

Summary: the objective of the study is to determine the incidence of faecal incontinence in prostate cancer survivors treated with moderately hypofractionated radiation therapy and correlate the dose received by the anal sphincter with the degree of faecal incontinence.

the investigators know that high doses of irradiation in the anal sphincter are associated with more chronic fecal leaks in survivors irradiated by normofractionated radiotherapy prostate cancer. the safe dose of irradiation of the anal sphincter with radiotherapy modern techniques (volumetric modulated arc therapy with moderately hypofracctionation) is unknown. urgency and faecal incontinence greatly affects the quality of life of these patients. therefore, it is interesting to implement strategies to protect the anatomical structures involved in fecal continence. the objective of the study is to determine the incidence of faecal incontinence in prostate cancer survivors treated with modern moderately hypofractionated radiation therapy and correlate the dose received by the anal sphincter with the degree of faecal incontinence. the investigators also want to evaluate the quality of life of these patients

Eligibility criteria:
inclusion criteria: * prostate cancer survivors treated in our department by hypofractionated radiotherapy exclusion criteria: * relapse of prostate cancer * other active cancer * mental disorder

Keywords: hypofractionated radiotherapy quality of life cancer survivors
effect of glutathione on blood alcohol and hangover symptoms

Conditions: Alcohol Drinking

Summary: glutathione (a tripeptide of 3 amino acids - glutamic acid, cysteine and glycine) plays a great role in homeostasis, especially as a potent anti-oxidant. as an anti-oxidant, it conjugates with xenobiotics using glutathione-s-transferase (gst) and excretes in urine as mercapturic acid. in 1986, casciani et al at the university of milan, studied the effect of glutathione on blood alcohol, acetaldehyde and hepatic triglyceride levels and found a significant reducing effect. the blood acetaldehyde, which is the metabolic product of ethyl alcohol may have a correlation with hangover symptoms. this study is designed to find this correlation using blood alcohol, blood acetaldehyde levels and the hangover symptoms scale according to the slutske et al study.

type of study: double-blinded control population: 100 males inclusion criteria: * males 20-40 years * healthy, without chronic diseases, especially must have normal hepatic function, measured by serum sgpt * no history of alcoholic allergy * drink alcohol regularly, at least once a week * agree to be a subject by standard consent form exclusion criteria: * subject wants to end the study * some impending danger to subjects number of subjects : 100 methodology 1. subjects are recruited; 2. history taking, physical examination and sgpt are done by m.d.; 3. 100 subjects are distributed randomly to numbers 1-100; 4. factory provides 2 groups of capsules in randomized packets numbered 1 -100; each package contains 3 sub-packages; each sub-package contains 2 capsules of either placebo or 370 mg glutathione capsules. all the three sub-packages will be all placebo or all glutathione. 50 packages are placebo and 50 packages are glutathione; 5. subjects are examined as follows: * hour 0: 3 ml of blood taken for blood alcohol and blood acetaldehyde; * hour 0- 1: consume thai whisky (40% alcohol) 60 ml with snacks; * hour 1: ml of blood taken for blood alcohol and blood acetaldehyde; * hour 1.30: ml of blood taken for blood alcohol and blood acetaldehyde; * hour 2.30: ml of blood taken for blood alcohol and blood acetaldehyde; * hour 3.30: ml of blood taken for blood alcohol and blood acetaldehyde; * hour 12: ml of blood taken for blood alcohol and blood acetaldehyde, and alcohol hangover symptom evaluation of each subject is done individually. using wendy s. slutske et al scale 0-4: 0= no symptom 1. minimal 2. some 3. much 4. most symptoms are 1. extreme thirst or dehydration 2. more tired than usual 3. headache 4. nausea 5. vomiting 6. very weak 7. difficulty concentrating 8. more sensitive to light and sound than usual 9. more sweating than usual 10. have a lot of trouble sleeping 11. anxious 12. depressed 13. trembling or shaking blood alcohol, blood acetaldehyde and hangover symptoms are statistically evaluated for significance.

Eligibility criteria:
inclusion criteria: * healthy * males 20-40 years old * no allergies to alcohol exclusion criteria: * chronic disease * increase in hepatic enzyme sgpt * impending danger

Keywords: hangover hangover symptoms
pharmacokinetics, safety, and tolerability of methylnaltrexone (mntx) in subjects with impaired renal function

Conditions: Renal Impairment

Summary: this study is evaluating the pharmacokinetics of mntx in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.


Eligibility criteria:
inclusion criteria: 1. body weight \>100 lbs. (\> 45 kg), and body mass index (bmi) between 18-38 kg/m2, inclusive (bmi 18-30 for the matched reference group) 2. for patients/subjects requiring pharmacotherapy, a stable drug regimen, defined as not having started a new drug or changed dosage within three (3) days or five (5) half-lives (whichever was longer) prior to administration of mntx concomitant medication must either have conformed to the list of approved drugs and dosage or have been approved by the sponsor. 3. patients with normal renal function, demographically comparable to the patients with impaired renal function weights and ages were within the range of chronic kidney disease (ckd) group and the average for the matched reference group was within 10 years and 10 kg of the average for the ckd 4. patients with impaired renal function, good general health except for those illnesses associated with ckd. exclusion criteria: 1. subjects/patients with any conditions possibly affecting drug absorption (eg. gastrectomy or clinically significant diabetic gastroenteropathy) 2. methadone use 3. consumption of grapefruit or grapefruit juice within seven (7) days prior to administration of study medication. 4. patients requiring hemodialysis.
harnessing placebo effects in methadone treatment

Conditions: Opioid-use Disorder; Opioid-Related Disorders

Summary: more than 2 million individuals in the united states have an opioid use disorder (oud). methadone maintenance treatment is the gold standard of medication-assisted treatment for oud, but high-dose methadone is associated with cardiotoxicity and respiratory complications, among other side effects. these adverse effects make enhancing the effectiveness of lower doses of methadone an attractive therapeutic goal. long recognized for its capacity to enhance treatment outcomes for a wide range of neuropsychiatric disorders including pain, the placebo effect offers an as-yet untested avenue to such an enhancement. this approach is particularly compelling given that individuals with substance use disorder tend to have higher salience attribution, and may thereby be more sensitive to placebo effects. our study combines two promising clinical methodologies-open-label placebo and conditioning-to investigate whether placebo effects can increase the effective potency of methadone in treatment-seeking oud patients.

a total of 120 newly-enrolled treatment-seeking oud patients will be randomly assigned to one of two different groups: either methadone plus daily open-label placebo (olp; treatment group), or methadone/treatment as usual (tau; control). participants will meet with study team members five times over the course of three months of treatment with methadone (baseline, 2 weeks, and 1, 2 and 3 months post-baseline). throughout this study time period, methadone dosages will be adjusted by an addiction clinician blind to patient assignment, per standard clinical methods. the primary outcome is methadone dose at three months. secondary outcomes include self-report of drug use; 3-month urine toxicology screen results; and treatment retention. exploratory outcomes include several environmental as well as personality factors associated with oud and with propensity to demonstrate a placebo effect.

Eligibility criteria:
inclusion criteria: * adult (age 18 or over) * newly-admitted to the methadone treatment program exclusion criteria: * pregnancy * transfers- patients who have initiated methadone treatment course at another methadone treatment facility * hospital transfers- patients who initiated methadone treatment course in a hospital setting * criminal justice referral

Keywords: medications for opioid use disorder methadone
cbt as an adjunct to sris in the treatment of bdd

Conditions: Body Dysmorphic Disorder

Summary: the research project is a controlled pilot study of the efficacy of cognitive-behavioral therapy (cbt) as an adjunct to serotonin reuptake inhibitor (sri) pharmacotherapy in body dysmorphic disorder (bdd). this study assesses the efficacy of cbt in comparison to relaxation and stress management training (rsmt), an active control treatment

in total, 20 bdd patients aged 16 through 65 will participate. to be eligible they must meet dsm-iv criteria for bdd, have a score of 20 or greater on the bdd modification of the yale brown obsessive-compulsive scale (bdd-ybocs) and be on a stable, therapeutic does of an sri (at least 12 weeks on the sri with 8 weeks at a therapeutic dose: acceptable medications (therapeutic daily doses) are citalopram (40mg), clomipramine (150mg), fluoxetine (40mg), fluvoxamine (150mg), paroxetine (40mg), sertraline (50mg), and venlafaxine (150mg).

Eligibility criteria:
inclusion criteria: * age 16-65 * a diagnosis of dsm-iv bdd or its delusional variant (delusional disorder, somatic type) * ability to communicate meaningfully with the investigators * competent to provide written consent, if over 18 years old, or competent to provide written assent, if 16-17 years, 11 months * parental consent, if under 18 years old * for phase two: must be on a stable therapeutic dose of one of the following sri medications for at least 8 weeks: fluoxetine, fluvoxamine, venlafaxine, clomipramine, paroxetine, citalopram, or sertraline. exclusion criteria: * current or lifetime diagnosis of any dsm_iv psychotic disorder not attributable to delusional bdd, current or lifetime diagnosis of dsm-iv bipolar disorder, * current or recent (within 2 months of study entry) dsm-iv alcohol or substance dependence or abuse, * recent suicide attempt, or suicidal ideation that warrants consideration of hospitalization, * need for inpatient or partial hospital treatment, * use of any medication prescribed for the treatment of bdd other than sris, including tricyclic antidepressants, buspirone, or neuroleptics, * presence of any significant and/or unstable medical condition, * females who are pregnant or breast-feeding, or who are sexually active and not using adequate contraception.

Keywords: body dysmorphic disorder sris cognitive behavioral therapy
real-world evaluation of prevalence of ocular adverse events in patients with neovascular (wet) agerelated macular degeneration (amd) who received anti-vegf agents (iris registry)

Conditions: Age-related Macular Degeneration (AMD)

Summary: in this cross-sectional study of patients with wet amd who received ≥1 anti-vegf injection (excluding brolucizumab), evidence was generated to describe the period prevalence of specific ocular aes. the study was conducted using the iris registry, and all results were based on the study period from 01/01/2019 to 12/31/2019.

this was a retrospective cohort study of eyes in adult patients with a diagnosis of wet amd who were treated with anti-vegf agents from 01/01/2019 to 12/31/2019. iris registry data from 01/01/2019 to 12/31/2019 for patients with a diagnosis of wet amd who were treated with ≥1 anti-vegf agent (excluding brolucizumab) were included. * identification period: patients fulfilling the selection criteria during the period from 01/01/2019 to 12/31/2019 were identified * index date: 01/01/2019 * study period: 01/01/2019 to 12/31/2019 * pre-index period: 01/01/2018 to 12/31/2018 * post-index period: 01/01/2019 to 12/31/2019

Eligibility criteria:
inclusion criteria: * ≥1 international classification of diseases, clinical modification-9/10 cm (icd- 9/10) code for wet amd in 2019 * ≥1 healthcare common procedure coding system (hcpcs) code (j code) or national drug code (ndc) code for treatment with an anti-vegf agent (excluding brolucizumab) in 2019 * ≥18 years old in 2019 * ≥2 wet amd-related office visits in 2019 exclusion criteria: * patient eyes that received \>1 type of anti-vegf treatment on the same date * patient eyes that did not have laterality any time during 2018-2019 * treatment with brolucizumab during 2019
efficacy optimizing research of lamivudine therapy

Conditions: Compensated Chronic Hepatitis B

Summary: the purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of lamivudine and adefovir de-novo combination therapy.


Eligibility criteria:
inclusion criteria: * male or female aged 18-65 years; * capable of understanding and signing the informed consent. willing to comply with the study requirements; * serum hbsag and hbeag positive at study screening; documented chronic hepatitis b infection determined by the presence of serum hbsag for at least 6 months; exclusion criteria: * history of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis; * other protocol defined inclusion/exclusion criteria

Keywords: chronic hepatitis b
study to evaluate safety,tolerability,pharmacodynamics & pharmacokinetics of jte-451 in active plaque psoriasis subjects

Conditions: Plaque Psoriasis; Psoriasis; Skin Diseases

Summary: study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of jte-451 administered for 4 weeks in subjects with active plaque psoriasis.


Eligibility criteria:
inclusion criteria: * minimum of two psoriatic plaques (i.e., one clinical target lesion and one biopsy target lesion). * each of the two target lesions must have a psoriatic lesion severity sum (plss) of ≥6 * body mass index (bmi) of 18 to 38 kg/m2 (inclusive) exclusion criteria: * prior exposure to \>2 systemic biologic agents and/or small molecules including investigational therapies for the treatment of psoriasis or have not discontinued systemic biologic agents and/or small molecules anti-psoriasis therapy including investigational therapies due to lack of efficacy; * subjects with significant health problems, other than having plaque psoriasis (as determined by medical history, physical examination, chest x-ray, vital signs and 12-lead ecg) that could either interfere with study evaluations or place subject at undue risk; * presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis at visit 1; * conditions (e.g., clinically-significant eczema or severe acne in the target lesion area) that would interfere with study evaluations; * positive quantiferon®-tb gold test, negative chest x-ray findings for tubercle bacillus (tb) or lack any other evidence of active or latent tb; * history of a clinically-significant infection (e.g., required oral antimicrobial therapy) within 4 weeks prior to visit 2; * subjects who do not have clinical laboratory test results within the normal reference ranges (i.e., are deemed not to be clinically significant) or clinically not acceptable to the investigator;

Keywords: jte-451 psoriasis
heparin versus saline in peripheral venous catheter

Conditions: Catheter-Related Infections

Summary: a clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter. patients will be randomized to either receive heparin or saline. the investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.

the need of use of peripheral venous catheters and the importance of a proper management to avoid catheter colonization or phlebitis requires two possible preventive approaches: lock therapy with heparin or saline. heparin demonstrated its efficacy in central venous catheters, but there are still controversies of whether it is useful in peripheral venous catheters. objectives to compare the efficacy of heparin in peripheral venous catheters lock versus saline for the prevention of colonization and phlebitis in patients admitted to an internal medicine department. methods: a clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter. patients will be randomized to either receive heparin or saline. the investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.

Eligibility criteria:
inclusion criteria: * patients with inserted pv catheter within 24h from admission in internal medicine exclusion criteria: * hypersensibility to heparin * active hemorrhage * coagulation alterations
evaluation of viatar™ oncopheresis system in removing ctc from whole blood

Conditions: Metastatic Cancer

Summary: this study will access the safety and efficacy of the viatar™ oncopheresis system to remove a meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon or prostate solid tumor cancers in a single treatment. ctc reduction will be measured as the change in circulating tumor cells as determined before and after treatment.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of breast, colon or prostate cancer * no prior cancer therapy or failed first line therapy * \>= 25 ctc per 7.5 ml of blood within 1 week prior to oncopheresis treatment * \> 1 month life expectancy * adequate baseline hematological function as assessed by the following laboratory values: * hemoglobin \> 9 g/dl * platelets \> 100,000/mm3 * wbc \> 3,000/mm3 * absolute neutrophil count \> 1,500/mm3 exclusion criteria: * coagulation disorders and/or a history of thromboembolic complications, including known hypersensitivity to citrate: e.g., abnormal platelet count, prothrombin time and partial activated thromboplastin time and with a history of deep vein thrombus or pulmonary embolism * patients with known immunodeficiency virus (hiv)